ICH E6(R3) Finalization – An Action Plan for Clinical Compliance Critical Impacts of ICH E6 (R3) and Business Process Updates for Clinical Trial Sponsors The release of ICH E6 (R3) ushers in a new era of clinical trial management, focusing heavily on risk management, quality by design, and enhanced oversight. While the updated guidance emphasizes principles, its implementation requires sponsors to translate these into actionable business process updates. Below, we outline practical examples of how sponsor organizations now need to adapt their processes to align with ICH E6 (R3).   

Hidden TMF Clinical Compliance Risks Inspectable Content Housed OUTSIDE the TMF In the fast-paced world of clinical trials, maintaining a robust and compliant Trial Master File (TMF) is essential for inspection readiness.  Yet, many sponsors inadvertently overlook critical TMF content that they generate during the trial, only to scramble for it during preparation for regulatory inspections or asset transfers. This oversight can create unnecessary stress and risk for organizations.   The TMF is defined as the collection of records that show that the trial is being conducted to regulatory requirements.  This

20 Years of Delivering Clinical Compliance Confidence   Founded in 2005, Just in Time GCP has empowered our partners with clinical compliance confidence for over 20 years. We align people, processes, and technologies with Good Clinical Practices (GCP) and your unique organizational goals, enhancing study success and providing you with peace of mind. Simplify GCP Compliance, Amplify Clinical Success Our team of over 100 full-time clinical experts offers comprehensive GCP compliance support, including: Upcoming inspection assistance System implementation solutions SOP creation Clinical oversight Asset acquisition Ongoing support Immediate remediations Quick quality

Pondering The “What Ifs” Of Inspection Readiness with Generative AI Just in Time GCP’s Founder and CEO, Donna Dorozinsky, contributed a guest column for Clinical Leader outlining the impact of generative AI on GCP inspection readiness.  She describes it’s transformative potential and how to prepare your clinical trials today for adoption and integration. Key Highlights Understanding Generative AI: An overview of the capabilities and benefits of generative AI in regulatory inspections. Navigating Complexities: Insights into the challenges organizations face in adopting this technology. Strategic Implementation: Best practices for integrating AI

Clinical Trial Master File Trends from 2024  As we approach 2025, the Clinical Trial Master File (TMF) landscape is undergoing substantial transformations driven by technological advancements and evolving regulatory requirements. At Just in Time GCP, we work with TMFs of all shapes and sizes, and this year, we have identified several clear trends that will significantly impact TMF management.  Increased Adoption of Electronic TMF (eTMF) Systems  The transition to electronic TMF (eTMF) systems is gaining traction, driven by several key developments:  Cloud-Based Solutions: An increasing number of clinical trials are

Just in Time GCP Welcomes George Lyon as Chief Commercial Officer  Just in Time GCP is excited to announce the appointment of George Lyon as our new Chief Commercial Officer.   “Excited to welcome George Lyon as Chief Commercial Officer at Just in Time GCP! George brings a wealth of expertise in business development and strategic growth, and his leadership will be instrumental as we expand our footprint in the industry. With George at the helm of our commercial strategy, we’re poised to forge new partnerships, drive innovation, and deliver